Pfizer Inc. (PFE) Thursday said the U.S. Food and Drug Administration, or FDA, has approved DUAVEE 0.45mg / 20mg, a once daily tablet indicated for the treatment of vasomotor symptoms associated with menopause and the prevention of postmenopausal osteoporosis.
"The approval of DUAVEE, an important, novel and effective treatment, presents a new opportunity for women and their doctors to discuss appropriate options for managing hot flashes and preventing osteoporosis, " said Gail Cawkwell, VP, Pfizer Medical Affairs.
The FDA approval is based on Phase III clinical trials, which evaluated the safety and efficacy of DUAVEE in generally healthy, postmenopausal women with a uterus for the treatment of moderate-to-severe hot flashes, and the prevention of postmenopausal osteoporosis.
During one of the trials, DUAVEE was observed to significantly reduce the number of moderate-to-severe hot flashes by 74 percent at 12 weeks, as compared with placebo. After 12 weeks of treatment, women taking DUAVEE experienced on average three hot flashes per day while women taking placebo had six.
In other clinical trials, DUAVEE was also observed to increase bone mineral density in the total hip and lumbar spine from baseline compared with decreases seen with placebo.
Some common side effects of DUAVEE include muscle spasms, nausea, diarrhea, upset stomach, abdominal pain, throat pain, dizziness and neck pain. Estrogen agonist, including bazedoxifene, are also known to increase blood clots.
The treatment is not advised to women who have had blood clots, or are allergic to any of its ingredients. Women who are pregnant or breastfeeding a baby are also to be avoided from the treatment. When prescribed for the prevention of postmenopausal osteoporosis, therapy is to be considered only for women at significant risk.
DUAVEE is said to be the first and only therapy to pair conjugated estrogens with an estrogen agonist. The therapy uses bazedoxifene to help protect the uterine lining against hyperplasia that may result from estrogen-alone treatment.
DUAVEE will be available in the U.S. in the first quarter of 2014.
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